MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER FOR DELTA BIO-INTERFERENCE SCREW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-1486
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The complaint device was requested but not returned and therefore the customer's complaint cannot be verified.Lot number was not provided so device history record review cannot be performed.Complaint's event is most likely caused by continually applying torque after the screw is fully seated, torquing when the implant is not properly aligned, torquing while leveraging the device and/or using the incorrect screw with the driver (screw does not seat fully on the driver).The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device requested but not yet returned.
Event or Problem Description
It was reported that during driving in of the screw, the tip of the screwdriver broke inside the screw.It was not possible to remove the broken piece.Additional information obtained 06 jun 2017: date of event was (b)(6) 2017 the patient is fine and there are no consequential damages for the patient.

• Brand Name: SCREWDRIVER FOR DELTA BIO-INTERFERENCE SCREW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6661152
• Report Number: 1220246-2017-00217
• Device Sequence Number: 1444599
• Product Code: LXH
• UDI-Device Identifier: 00888867004252
• UDI-Public: 00888867004252
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AR-1486
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other